- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …(T0 - T1) or early development (phase 1) assets either within Medical Affairs, Regulatory Affairs, or Clinical Development is preferred. + Minimum of 7+ years ... and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay...closely with other key functions, including regional medical leads, clinical development, global value and real-world evidence, US and… more
- Sam Houston State University (Huntsville, TX)
- …and healthcare practices, with a comprehensive understanding of the ethical, regulatory , and clinical considerations involved in healthcare AI. Experience ... within the medical school, prepares students with the technical, ethical, and clinical expertise needed to advance AI integration in healthcare and medical research.… more
- Houston Methodist (Houston, TX)
- …Procedures (SOPs), and study specific protocols/plans and processes. The Sr Regulatory Compliance Specialist position maintains documentation for clinical ... At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading,...Regulatory Affairs Certifications (RAPS) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRP - Certified … more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- … trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be ... + ** Regulatory Authority Engagement:** Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any… more
- Koniag Government Services (San Antonio, TX)
- …devices and other specialized endpoints, balancing security requirements with clinical functionality and regulatory compliance.Generates regular reports on ... adhere to established endpoint management policies and procedures. + Collaborates with clinical engineering teams to develop secure management strategies for medical… more
- UTMB Health (Galveston, TX)
- Regulatory Scientist I / II - Institutional Office of Regulated Nonclinical Studies (ORNcs) **Galveston, Texas, United States** Research Academic & Clinical UTMB ... Health Requisition # 2402210 **JOB DESCRIPTION** Function: The Regulatory Scientist II will be assigned as a Study Director, as defined by the US FDA Good Laboratory… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Sumitomo Pharma (Austin, TX)
- …business questions and relevant cross-functional stakeholders, including in Commercial, Clinical Development, Medical Affairs, Regulatory , Sales leadership and ... should identify and effectively communicate regarding overarching corporate strategies, clinical development programs, and commercial capabilities of key competitors,… more
- Sumitomo Pharma (Austin, TX)
- …a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/she...strategies to optimize the commercial success of products for clinical trials, labeling, etc. + Develop and maintain productive… more
- Cardinal Health (Austin, TX)
- …evolution + Collaborate with partners across enterprise, including R&D, Regulatory , Clinical Affairs, Sourcing, Manufacturing, Strategy Functions, Downstream ... Marketing, International Business Partners, etc. + Explore technology and connectivity applications + Support inorganic, or BD&L, pipeline activities + Help identify market opportunities through primary and secondary market research and act by implementing and… more
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